Gut microbiota-derived synbiotic formula (SIM01) as a novel adjuvant therapy for COVID-19: An open-label pilot study
Zhang et al.,
Gut microbiota-derived synbiotic formula (SIM01) as a novel adjuvant therapy for COVID-19: An open-label pilot..,
Journal of Gastroenterology and Hepatology, doi:10.1111/jgh.15796, NCT04581018
Pilot study of probiotic SIM01 with 25 consecutive COVID-19 patients in Hong Kong and 30 control patients treated by a different team during the same time period, showing improved antibody formation, reduced viral load and pro-inflammatory responses, and improvements for gut dysbiosis. SIM01 contains bifidobacteria strains, galactooligosaccharides, xylooligosaccharide, and resistant dextrin (derived from metagenomic databases of COVID-19 patients and healthy patients).
The immune effects of probiotics are strain-specific.
risk of mechanical ventilation, 64.7% lower, RR 0.35, p = 1.00, treatment 0 of 25 (0.0%), control 1 of 30 (3.3%), NNT 30, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of no antibody formation, 67.3% lower, RR 0.33, p = 0.06, treatment 3 of 25 (12.0%), control 11 of 30 (36.7%), NNT 4.1.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Zhang et al., 2 Mar 2022, retrospective, China, peer-reviewed, 12 authors, trial
NCT04581018 (history).
Contact:
siewchienng@cuhk.edu.hk, fklchan@cuhk.edu.hk.
Abstract: bs_bs_banner
doi:10.1111/jgh.15796
CLINICAL TRIAL
Gut microbiota-derived synbiotic formula (SIM01) as a novel
adjuvant therapy for COVID-19: An open-label pilot study
Lin Zhang,*,†,‡1
Zhilu Xu,*,†,‡1
Joyce W Y Mak,*,†,‡
Kai Ming Chow,† Grace Lui,†,§ Timothy C M Li,†
¶
†
Chun Kwok Wong, Paul K S Chan,** Jessica Y L Ching,
Yasuhiro Fujiwara,†† Francis K L Chan*,†,‡ and
,†,‡
Siew C Ng*
*Microbiota I-Center (MagIC), †Department of Medicine and Therapeutics, Faculty of Medicine, ‡State Key Laboratory of Digestive Disease, Institute of
Digestive Disease, Li Ka Shing Institute of Health Sciences, Faculty of Medicine, §Stanley Ho Centre for Emerging Infectious Diseases, Faculty of Medicine,
¶
Department of Chemical Pathology, Faculty of Medicine, **Department of Microbiology, Faculty of Medicine, The Chinese University of Hong Kong, Hong
Kong SAR, China; and ††Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan
Key words
immunity, microbiota, probiotics, SARS-CoV-2.
Accepted for publication 3 February 2022.
Correspondence
Siew C Ng and Francis K L Chan, Department of
Medicine and Therapeutics, The Chinese
University of Hong Kong, Hong Kong SAR,
China.
Email: siewchienng@cuhk.edu.hk;
fklchan@cuhk.edu.hk
Declaration of conflict of interest: Prof. Siew
Ng and Prof. Francis Chan report serving as
founder member for GenieBiome Limited. Prof.
Siew Ng also has served as advisory board
member for Pfizer, Ferring, Janssen, Abbvie
and speaker for Ferring, Tillotts, Menarini,
Janssen, Abbvie, and Takeda. She has received
research grants from Olympus, Ferring and
Abbvie. Prof. Francis Chan has served as the
Director & Board member of CUHK Medical
Centre Limited and First Director of the Board
of Directors for CUHK Multi-Scale Medical Robotics Centre Limited. He also has served as
advisor and lecture speaker for Eisai Co. Ltd,
AstraZeneca, Pifzer Inc, Takeda Pharmaceutical
Co., Takeda (China) Holdings Co. Ltd. Prof.
Siew Ng, Prof. Francis Chan, and Dr Zhilu Xu are
inventors of patent applications for “Composition for Improving Immunity”
(CN202010657312.5, CN202011259564.9,
CN202110223880.9, PCT/CN2021/090531, and
TW110115155). Prof. Siew Ng and Prof. Francis
Chan are inventors of patent applications for
Abstract
Background and Aim: Gut dysbiosis is associated with immune dysfunction and severity
of COVID-19. Whether targeting dysbiosis will improve outcomes of COVID-19 is unknown. This study aimed to assess the effects of a novel gut microbiota-derived synbiotic
formula (SIM01) as an adjuvant therapy on immunological responses and changes in gut
microbiota of hospitalized COVID-19 patients.
Methods: This was an open-label, proof-of-concept study. Consecutive COVID-19 patients admitted to an infectious disease referral center in Hong Kong were given a novel
formula of Bifidobacteria strains, galactooligosaccharides, xylooligosaccharide, and resistant dextrin (SIM01). The latter was derived from metagenomic databases of COVID-19
patients and healthy population. COVID-19 patients who were admitted under another independent infectious disease team during the same period without receiving SIM01 acted
as controls. All patients received standard treatments for COVID-19 according to the hospital protocol. We assessed antibody response, plasma proinflammatory markers, nasopharyngeal SARS-CoV-2 viral load, and fecal microbiota profile from admission up to week 5.
Results: Twenty-five consecutive COVID-19 patients received..
Late treatment
is less effective
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